Sanbor Medical Xiamen, Inc. · 89-08 · CHINA
For Sanbor Medical Xiamen, Inc. · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is ReBuilder 300 System; ReBuilder 2407 Personal System | ReBuilder 300 System; ReBuilder 2407 Personal System; product code is 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered; date published is 03/01/2011; address is 1776 Lv Ling Road , Xiamen, Fujian CHINA, verified against its source on 2026-09-16.
- Firm
- Sanbor Medical Xiamen, Inc. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- 1776 Lv Ling Road , Xiamen, Fujian CHINA verified
- Date published
- 03/01/2011 verified
- Product code
- 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered each item verified
- Product
- ReBuilder 300 System; ReBuilder 2407 Personal System | ReBuilder 300 System; ReBuilder 2407 Personal System each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Sanbor Medical Xiamen, Inc. Date Published : 03/01/2011 1776 Lv Ling Road , Xiamen, Fujian CHINA 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 03/01/2011 Desc: ReBuilder 300 System; ReBuilder 2407 Personal System Notes: Class II 89 I - - PF Stimulator, Muscle, Powered Date Published: 03/01/2011 Desc: ReBuilder 300 System; ReBuilder 2407 Personal System Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.